MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MITRIS RESILIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	11400M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: attempts have been made to obtain product for evaluation.No device was returned.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
It was learned through implant patient registry and investigation that a 27 mm 11400m mitral valve was explanted after an implant duration of one (1) month, and one (1) day due to endocarditis (staphylococcus lugdenensis) with severe stenosis.The patient presented with heart failure, fatigue, palpitation, and dyspnea.The explanted valve was replaced with another 27 mm 11400m mitral valve.Per medical records, the patient presented with fevers and malaise.She recently had mvr done in (b)(6) 2025.The patient underwent redo-mvr with a 27 mm 11400m valve, tvr with 31 mm mitris valve, repair of mitral annular abscess, and removal of ppm.Intraoperatively, the mv was completely overgrown with thrombus or vegetation.Post bypass tee showed new mv and tv valve were well seated with no pvl.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
H11: additional manufacturer narrative:.Based on the additional information obtained, the failure mode was due to endocarditis.H11.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
It was learned through implant patient registry and investigation that a 27mm 11400m mitral valve was explanted after an implant duration of one (1) month, and one (1) day due to endocarditis (staphylococcus lugdenensis) with severe stenosis.The patient presented with heart failure, fatigue, palpitation, and dyspnea.The explanted valve was replaced with another 27mm 11400m mitral valve.Per medical records, the patient presented with fevers and malaise.She recently had mvr done in m(b)(6) 2025.The patient underwent redo-mvr with a 27mm 11400m valve, tvr with 31mm mitris valve, repair of mitral annular abscess, and removal of ppm.Intraoperatively, the mv was completely overgrown with thrombus or vegetation.Post bypass tee showed new mv and tv valve were well seated with no pvl.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES, LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 22627896
• Report Number: 2015691-2025-06077
• Device Sequence Number: 12759823
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)290924(11)240925
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 11400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/10/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female